Fluid Restriction Mechanisms For Drug Delivery Pumps

ABSTRACT

A replaceable fluid restriction mechanism 500, 1500 includes: an aperture 520A residing adjacent to a fluid pathway connection and configured to permit flow of a drug fluid through the aperture 520A when the fluid pathway connection is open; an entry point 520B of a fluid channel 520C configured such that the flow of drug fluid can travel through aperture 520A to the entry point 520B and through the fluid channel 520C to an exit point 520D; and an outlet aperture 514 of a port 512 through which the flow of drug fluid may travel after exiting the exit point 520D, wherein a fluid conduit 30 is connected to the fluid restriction mechanism at the outlet aperture. A configurable fluid restriction mechanism 500, 1500 includes a plurality of fluid channels 520C, 521C, 522C, 523C, selectable to align with the entry point 520B and an exit point 520D of the fluid restriction mechanism.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.61/756,556, filed on Jan. 25, 2013, which is included by referenceherein in its entirety for all purposes.

FIELD

THIS INVENTION relates to drug delivery pumps. More particularly, thisinvention relates to fluid restriction mechanisms for the controlleddelivery of drug substances and drug delivery pumps which incorporatesuch fluid restriction mechanisms.

BACKGROUND

Parenteral delivery of various drugs, i.e., delivery by means other thanthrough the digestive track, has become a desired method of drugdelivery for a number of reasons. This form of drug delivery byinjection may enhance the effect of the substance being delivered andensure that the unaltered medicine reaches its intended site at asignificant concentration. Similarly, undesired side effects associatedwith other routes of delivery, such as systemic toxicity, canpotentially be avoided through parenteral delivery. By bypassing thedigestive system of a mammalian patient, one can avoid degradation ofthe active ingredients caused by the catalytic enzymes in the digestivetract and liver and ensure that a necessary amount of drug, at a desiredconcentration, reaches the targeted site.

Traditionally, manually operated syringes and injection pens have beenemployed for delivering parenteral drugs to a patient. More recently,parenteral delivery of liquid medicines into the body has beenaccomplished by administering bolus injections using a needle andreservoir, continuously by gravity driven dispensers, or via transdermalpatch technologies. Bolus injections often imperfectly match theclinical needs of the patient, and usually require larger individualdoses than are desired at the specific time they are given. Continuousdelivery of medicine through gravity-feed systems compromises thepatient's mobility and lifestyle, and limits the therapy to simplisticflow rates and profiles. Another form of drug delivery, transdermalpatches, similarly has its restrictions. Transdermal patches oftenrequire specific molecular drug structures for efficacy, and the controlof the drug administration through a transdermal patch is severelylimited.

Ambulatory infusion pumps have been developed for delivering liquidmedicaments to a patient. These infusion devices have the ability tooffer sophisticated fluid delivery profiles accomplishing bolusrequirements, continuous infusion and variable flow rate delivery. Theseinfusion capabilities usually result in better efficacy of the drug andtherapy and less toxicity to the patient's system. Currently availableambulatory infusion devices are expensive, difficult to program andprepare for infusion, and tend to be bulky, heavy and very fragile.Filling these devices can be difficult and require the patient to carryboth the intended medication as well as filling accessories. The devicesoften require specialized care, maintenance, and cleaning to assureproper functionality and safety for their intended long-term use, andare not cost-effective for patients or healthcare providers.

As compared to syringes and injection pens, pump type delivery devicescan be significantly more convenient to a patient, in that doses of thedrug may be calculated and delivered automatically to a patient at anytime during the day or night. Furthermore, when used in conjunction withmetabolic sensors or monitors, pumps may be automatically controlled toprovide appropriate doses of a fluidic medium at appropriate times ofneed, based on sensed or monitored metabolic levels. As a result, pumptype delivery devices have become an important aspect of modern medicaltreatments of various types of medical conditions, such as diabetes, andthe like.

While pump type delivery systems have been utilized to solve a number ofpatient needs, manually operated syringes and injection pens oftenremain a preferred choice for drug delivery as they now provideintegrated safety features and can easily be read to identify the statusof drug delivery and the end of dose dispensing. However, manuallyoperated syringes and injections pens are not universally applicable andare not preferred for delivery of all drugs. There remains a need for aconfigurable drug delivery system that is precise and reliable and canoffer clinicians and patients a small, low cost, light weight, simple touse alternative for parenteral delivery of liquid medicines.

SUMMARY

The embodiments of the present invention provide selectably replaceable,configurable, and/or stackable fluid restriction mechanisms for usewithin a drug delivery pump system. The fluid restriction mechanisms mayinclude one or more selectable fluid pathways or channels to meet arange of desired fluid restriction parameters. Each restrictionmechanism may have multiple selectable pathways, or a single pathwaywith passages that may be opened or closed to modify the fluid pathwayprior to assembly. The fluid restriction plates may also includepermeable membranes to permit venting of gaseous fluids from the fluidpathway. The pump type drug delivery systems which include such fluidpathway systems and fluid restriction mechanisms are capable of beingprimed to reduce or eliminate gaseous fluids from the fluid pathwaysystem prior to introduction of a liquid fluid to a patient. Whendelivering fluid subcutaneously it is important to minimize or eliminatethe amount of gaseous fluid that is delivered into the patient. Deliveryof gaseous fluids, such as air or inert gases, is correlated toincreased perception of pain for patients and may adversely affectabsorption profiles of pharmaceutical treatments. As such, it isimportant to minimize or eliminate such gaseous fluids from the systemprior to injection of the drug. The fluid restriction mechanisms arealso easily configurable to permit the manufacture of one type ofmechanism (e.g., plate, chip, etc.) while enabling customization of thefluid restriction mechanism prior to or during assembly to enable arange of fluid restriction parameters.

As described herein, a single restriction mechanism may have a number ofselectable fluid pathways or channels with different restrictionparameters. Based on the desired fluid flow characteristics, themanufacturer or assembler can select the appropriate fluid pathway andassemble the components such that the desired fluid pathway is utilized.Similarly, the fluid pathways may be opened or closed by theassembler/manufacturer to enable longer or shorter fluid pathways, asmay be desired to meet the particular flow characteristics. While theseare important and desirable features of drug delivery devices, suchfeatures should not be cumbersome or complicated for the user. Theinventors of the present invention have developed a system which enablesthe configurability of the fluid restriction mechanisms and also thereduction or elimination of gaseous fluids from the fluid pathway, butyet is easy to use for clinicians and patients.

When delivering fluid subcutaneously it is important to control orrestrict the flow of fluid that is delivered into the patient. A drugpump, such as an infusion pump or a bolus injector, may be needed todeliver a particular amount of drug fluid within a period of time. Theflow of drug fluid, however, may need to be restricted as it passesthrough the system from a drug container to the needle insertionmechanism and into the patient. Some drug pump systems may utilize oneor more an active fluid restriction mechanisms, one or more passivefluid restriction mechanisms, or a combination of both. The presentinvention provides configurable fluid restriction mechanisms (e.g.,plates, chips, etc.) for microfluidic pathways which can be readilyintegrated into a pump type delivery device within the fluid pathwaybetween the drug container and the needle insertion mechanism.

The pump type delivery devices may be connected in fluid flowcommunication to a patient or user, for example, through any suitablehollow tubing. The hollow tubing may be connected to a hollow needlethat is designed to pierce the skin of the patient and to deliver afluidic medium there-through. Alternatively, the hollow tubing may beconnected directly to the patient as through a cannula, or the like. Asa further option, a solid bore needle may be used to pierce the skin ofthe patient and place a hollow cannula at the appropriate deliveryposition, with the solid bore needle being removed or retracted prior todrug delivery to the patient. As stated above, the fluid can beintroduced into the body through any number of means, including but notlimited to: an automatically inserted needle, cannula, micro-needlearray, or infusion set tubing. The flow of fluid may be initiated by anumber of different drive mechanisms which push a plunger seal within adrug container, thereby forcing a drug fluid out of the drug container.In at least one embodiment, the drive mechanism may be a spring-baseddrive mechanism that utilizes one or more springs to drive or push theplunger seal. The activation of the drive mechanism and the pushing ofthe plunger seal may occur before or after a fluid connection iscompleted, or itself may first cause a fluid connection to be madebefore forcing fluid through the fluid connection. Once the fluid flowis initiated, the fluid restriction mechanisms of the present inventionmay be utilized to control the duration of fluid flow through the drugpump. The fluid restriction mechanism may be located between the drugcontainer and the fluid conduit leading to the insertion mechanism, orat one or more locations within the fluid pathway from drug container topatient through the insertion mechanism.

In a first embodiment, the present invention provides a selectivelyreplaceable fluid restriction mechanism for a drug delivery pump. Thefluid restriction mechanism includes an aperture residing adjacent to afluid pathway connection and configured to permit flow of a drug fluidthrough the aperture when the fluid pathway connection is open; an entrypoint of a fluid channel configured such that the flow of drug fluid cantravel through aperture to the entry point and through the fluid channelto an exit point; and an outlet aperture of a port through which theflow of drug fluid may travel after exiting the exit point, wherein afluid conduit is connected to the fluid restriction mechanism at theoutlet aperture. The selectively replaceable fluid restriction mechanismmay further include a vent aperture to vent air or gas from a proximalside of the fluid restriction mechanism to a distal side of the fluidrestriction mechanism; and a membrane to facilitate the passage of airor gas in one direction while preventing fluid passage therethrough. Themembrane may be a permeable membrane.

In another embodiment, the present invention provides a configurablefluid restriction mechanism for a drug delivery pump which includes anaperture residing adjacent to a fluid pathway connection and configuredto permit flow of a drug fluid through the aperture when the fluidpathway connection is open; an entry point configured such that the flowof drug fluid can travel through aperture to the entry point; aplurality of fluid channels, selectable to align with the entry pointand an exit point of the fluid restriction mechanism; and an outletaperture of a port through which the flow of drug fluid may travel afterexiting the exit point, wherein a fluid conduit is connected to thefluid restriction mechanism at the outlet aperture. The configurablefluid restriction mechanism may include a vent aperture to vent air orgas from a proximal side of the fluid restriction mechanism to a distalside of the fluid restriction mechanism; and a membrane to facilitatethe passage of air or gas in one direction while preventing fluidpassage therethrough. The plurality of fluid channels may vary in lengthto provide different durations of travel for the flow of drug fluid,and/or the plurality of fluid channels may vary in diameter to providedifferent fluid restrictions to the flow of drug fluid.

In at least one embodiment, a plurality of the configurable fluidrestriction mechanisms may be connected in series in a stackedconfiguration, and wherein the aperture of the first fluid restrictionmechanism resides adjacent to a fluid pathway connection and configuredto permit flow of a drug fluid through the aperture when the fluidpathway connection is open, and the fluid conduit is connected to theoutlet aperture of the last fluid restriction mechanism in the stackedconfiguration. In another embodiment, the one selectively opened topermit the flow of drug fluid, and/or selectively closed to prevent theflow of drug fluid. In at least one embodiment, one or more fluidchannels may be connected to each other to increase the duration oftravel that the drug fluid must flow through. The fluid restrictionmechanisms may be in the shape of a disc, a spheroid, a square, asphere, a cube, a rectangle, or a pyramid.

In yet another embodiment, the present invention provides a drugdelivery pump with fluid delivery control which includes a housing,within which an activation mechanism, an insertion mechanism, a drugcontainer having a plunger seal may be mounted, and one or more of thefluid restriction mechanisms described above, wherein the drug containeris connected at one end to a drive mechanism and at another end to afluid pathway connection, and the fluid restriction mechanism isconnected at one end to the fluid pathway connection and at the otherend to a fluid conduit, and the fluid conduit is connected at anotherend to the insertion mechanism; such that the fluid restrictionmechanism is configured to restrict or control a flow of a drug fluidfrom the drug container to the insertion mechanism. The fluidrestriction mechanism may be a component of the fluid pathway connectionmounted to and integrated within the barrel of a drug container, or thefluid restriction mechanism may be a component adjacent to the fluidpathway connection and configured to restrict the flow of drug fluidfrom the barrel of a drug container through the drug pump once the fluidpathway connection is opened. Alternatively, the fluid restrictionmechanism may be connected to the fluid pathway connection by a firstfluid conduit, and the fluid restriction mechanism is connected to theinsertion mechanism by a second fluid conduit, such that the flow ofdrug fluid is restricted between the drug container and the insertionmechanism by the fluid restriction mechanism.

The novel embodiments of the present invention provide fluid restrictionmechanisms which are capable of controlling, providing resistance, orotherwise preventing free fluid flow of a drug substance out of a drugcontainer and, thereby, controlling the rate of delivery of drugsubstances. The present invention also provides drug pumps which utilizesuch fluid restriction mechanisms. Throughout this specification, unlessotherwise indicated, “comprise,” “comprises,” and “comprising,” orrelated terms such as “includes” or “consists of,” are used inclusivelyrather than exclusively, so that a stated integer or group of integersmay include one or more other non-stated integers or groups of integers.As will be described further below, the embodiments of the presentinvention may include or utilizes one or more additional componentswhich may be considered standard components in the industry of medicaldevices. For example, the embodiments may utilize certain medical gradeadhesives to affix components together. The components, and theembodiments containing such components, are within the contemplation ofthe present invention and are to be understood as falling within thebreadth and scope of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The following non-limiting embodiments of the invention are describedherein with reference to the following drawings, wherein:

FIG. 1A shows an isometric view of a drug delivery pump having a fluidrestriction mechanism, according to one embodiment of the presentinvention;

FIG. 1B shows an isometric view of the interior components of the drugdelivery pump shown in FIG. 1A (shown without the adhesive patch);

FIG. 1C shows an isometric view of the bottom of the drug delivery pumpshown in FIG. 1A (shown without the adhesive patch);

FIG. 2A shows an isometric view of a fluid restriction mechanism,according to at least one embodiment of the present invention, attachedto an integrated sterile fluid pathway connection and drug container,

FIG. 2B shows an exploded isometric view of the fluid restrictionmechanism, and integrated sterile fluid pathway connection and drugcontainer, shown in FIG. 2A;

FIG. 2C shows a side view of the fluid restriction mechanism shown inFIG. 2A;

FIG. 3A shows an isometric view of a fluid restriction mechanism,according to another embodiment of the present invention, attached to asterile fluid pathway connection which may or may not be integratedwithin the drug container;

FIG. 3B shows an exploded isometric view of the fluid restrictionmechanism, and sterile fluid pathway connection and drug container,shown in FIG. 3A;

FIG. 3C shows a side view of the fluid restriction mechanism shown inFIG. 3A;

FIG. 4A shows an exploded isometric view of the fluid restrictionmechanism shown in FIGS. 2A-2C;

FIG. 4B shows another angle of the exploded isometric view of the fluidrestriction mechanism shown in FIG. 4A;

FIG. 4C shows a cross-sectional view of the fluid restriction mechanismshown in FIGS. 4A-4B;

FIG. 5A shows an exploded isometric view of a configurable fluidrestriction mechanism, according to another embodiment of the presentinvention;

FIG. 5B shows a front view of the configurable fluid restrictionmechanism shown in FIG. 5A;

FIG. 6A shows an isometric view of a stackable fluid restrictionmechanism, according to another embodiment of the present invention;

FIG. 6B shows an exploded isometric view of the stackable fluidrestriction mechanism shown in FIG. 6A;

FIG. 7A shows an isometric view of a fluid restriction mechanism,according to a further embodiment of the present invention;

FIG. 7B shows the isometric view of the fluid restriction mechanismshown in FIG. 7A, with the top component of the fluid restrictionmechanism removed.

DETAILED DESCRIPTION

The present invention provides fluid restriction mechanisms for thecontrolled delivery of drug substances and drug delivery pumps whichincorporate such fluid restriction mechanisms. The fluid restrictionmechanisms of the present invention control the rate of drug delivery byproviding resistance and/or increasing the length of the fluid deliverypathway from the drug container to the needle insertion mechanism, fordrug delivery into the patient. Additionally, the fluid restrictionmechanisms of the present invention may be readily replaceable,configurable, and/or stackable to provide a range of fluid pathways andto meet a myriad of drug delivery needs. For example, the manufacturer,drug-filler, assembler, or another member of the production process mayselect and insert the necessary fluid restriction mechanism to meet thedesired drug delivery profile. This selection and insertion may beperformed by initial placement or replacement of the fluid restrictionmechanism. Additionally or alternatively, this may be performed byadjusting the fluid restriction mechanism, such as by rotation of aconfigurable fluid restriction mechanism having a plurality of fluidpathway channels or by open the desired fluid pathway channels of amulti-channel mechanism. Additionally or alternatively, the fluiddelivery profile may be met by utilizing a multitude of fluidrestriction mechanisms, at least in part, in a series configuration orin a parallel configuration. Each of these variations of the fluidrestriction mechanism may be utilized to meet the desired fluid deliveryprofile from the drug delivery pump.

As used herein to describe the fluid restriction mechanisms, drugdelivery pumps, or any of the relative positions of the components ofthe present invention, the terms “axial” or “axially” refer generally toa longitudinal axis “A” around which the mechanisms are preferablypositioned, although not necessarily symmetrically there-around. Theterm “radial” refers generally to a direction normal to axis A. Theterms “proximal,” “rear,” “rearward,” “back,” or “backward” refergenerally to an axial direction in the direction “P”. The terms“distal,” “front,” “frontward,” “depressed,” or “forward” refergenerally to an axial direction in the direction “D”. As used herein,the term “glass” should be understood to include other similarlynon-reactive materials suitable for use in a pharmaceutical gradeapplication that would normally require glass, including but not limitedto certain non-reactive polymers such as cyclic olefin copolymers (COC)and cyclic olefin polymers (COP). The term “plastic” may include boththermoplastic and thermosetting polymers. Thermoplastic polymers can bere-softened to their original condition by heat; thermosetting polymerscannot. As used herein, the term “plastic” refers primarily to moldablethermoplastic polymers such as, for example, polyethylene andpolypropylene, or an acrylic resin, that also typically contain otheringredients such as curatives, fillers, reinforcing agents, colorants,and/or plasticizers, etc., and that can be formed or molded under heatand pressure. As used herein, the term “plastic” is not meant to includeglass, non-reactive polymers, or elastomers that are approved for use inapplications where they are in direct contact with therapeutic liquidsthat can interact with plastic or that can be degraded by substituentsthat could otherwise enter the liquid from plastic. The term“elastomer,” “elastomeric” or “elastomeric material” refers primarily tocross-linked thermosetting rubbery polymers that are more easilydeformable than plastics but that are approved for use withpharmaceutical grade fluids and are not readily susceptible to leachingor gas migration under ambient temperature and pressure. “Fluid” refersprimarily to liquids, but can also include suspensions of solidsdispersed in liquids, and gasses dissolved in or otherwise presenttogether within liquids inside the fluid-containing portions of the drugpumps. According to various aspects and embodiments described herein,reference is made to a “biasing member”, such as in the context of oneor more biasing members for asserting force on a plunger seal. It willbe appreciated that the biasing member may be any member that is capableof storing and releasing energy. Non-limiting examples include a spring,such as for example a coiled spring, a compression or extension spring,a torsional spring, or a leaf spring, a resiliently compressible orelastic band, or any other member with similar functions. In at leastone embodiment of the present invention, the biasing member is a spring,preferably a compression spring.

The novel devices of the present invention provide fluid restrictionmechanisms to control (by restriction) the rate of drug delivery anddrug delivery pumps which incorporate such fluid restriction mechanisms.Such drug delivery devices are safe and easy to use, and areaesthetically and ergonomically appealing for self-administeringpatients. The devices described herein incorporate features which makeactivation, operation, and lock-out of the device simple for evenuntrained users. The novel devices of the present invention providethese desirable features without any of the problems associated withknown prior art devices. Certain non-limiting embodiments of the noveldrug delivery pumps, fluid control mechanisms, and their respectivecomponents are described further herein with reference to theaccompanying figures.

As used herein, the term “pump” is intended to include any number ofdrug delivery systems which are capable of dispensing a fluid to a userupon activation. Such drug delivery systems include, for example,injection systems, infusion pumps, bolus injectors, and the like. FIGS.1A-1C show an exemplary drug delivery device according to at least oneembodiment of the present invention. The drug delivery device may beutilized to administer delivery of a drug treatment into a body of auser. As shown in FIGS. 1A-1C, the drug pump 10 includes a pump housing12. Pump housing 12 may include one or more housing subcomponents whichare fixedly engageable to facilitate easier manufacturing, assembly, andoperation of the drug pump. For example, drug pump 10 includes a pumphousing 12 which includes an upper housing 12A and a lower housing 12B.The drug pump may further include an activation mechanism 14, a statusindicator 16, and a window 18. Window 18 may be any translucent ortransmissive surface through which the operation of the drug pump may beviewed. As shown in FIG. 1B, drug pump further includes assemblyplatform 20, sterile fluid conduit 30, drive mechanism 100 having drugcontainer 50, insertion mechanism 200, fluid pathway connection 300, andpower and control system 400. The fluid restriction mechanism 500 may beconnected to the sterile fluid conduit 30, preferably, between the fluidpathway connection 300 and the insertion mechanism 200. One or more ofthe components of such drug pumps may be modular in that they may be,for example, pre-assembled as separate components and configured intoposition onto the assembly platform 20 of the drug pump 10 duringmanufacturing.

The pump housing 12 contains all of the device components and provides ameans of removably attaching the device 10 to the skin of the user. Thepump housing 12 also provides protection to the interior components ofthe device 10 against environmental influences. The pump housing 12 isergonomically and aesthetically designed in size, shape, and relatedfeatures to facilitate easy packaging, storage, handling, and use byusers who may be untrained and/or physically impaired. Furthermore, theexternal surface of the pump housing 12 may be utilized to provideproduct labeling, safety instructions, and the like. Additionally, asdescribed above, housing 12 may include certain components, such asstatus indicator 16 and window 18, which may provide operation feedbackto the user.

In at least one embodiment, the drug pump 10 provides an activationmechanism 14 that is displaced by the user to trigger the start commandto the power and control system 400. In a preferred embodiment, theactivation mechanism is a start button 14 that is located through thepump housing 12, such as through an aperture between upper housing 12Aand lower housing 12B, and which contacts a control arm 40 of the powerand control system 400. In at least one embodiment, the start button 14may be a push button, and in other embodiments, may be an on/off switch,a toggle, or any similar activation feature known in the art. The pumphousing 12 also provides a status indicator 16 and a window 18. In otherembodiments, one or more of the activation mechanism 14, the statusindicator 16, the window 18, and combinations thereof may be provided onthe upper housing 12A or the lower housing 12B such as, for example, ona side visible to the user when the drug pump 10 is placed on the bodyof the user. Housing 12 is described in further detail hereinafter withreference to other components and embodiments of the present invention.

The drug pump is configured such that, upon activation by a user bydepression of the activation mechanism, the drug pump is initiated to:insert a fluid pathway into the user; enable, connect, or open necessaryconnections between a drug container, a fluid pathway, and a sterilefluid conduit; and force drug fluid stored in the drug container throughthe fluid pathway and fluid conduit for delivery into a user. One ormore optional safety mechanisms may be utilized, for example, to preventpremature activation of the drug pump. For example, an optional on-bodysensor 24 (shown in FIG. 1C) may be provided in one embodiment as asafety feature to ensure that the power and control system 400, or theactivation mechanism, cannot be engaged unless the drug pump 10 is incontact with the body of the user. In one such embodiment, the on-bodysensor 24 is located on the bottom of lower housing 12B where it maycome in contact with the user's body. Upon displacement of the on-bodysensor 24, depression of the activation mechanism is permitted.Accordingly, in at least one embodiment the on-body sensor 24 is amechanical safety mechanism, such as for example a mechanical lock out,that prevents triggering of the drug pump 10 by the activation mechanism14. In another embodiment, the on-body sensor may be anelectro-mechanical sensor such as a mechanical lock out that sends asignal to the power and control system 400 to permit activation. Instill other embodiments, the on-body sensor can be electrically basedsuch as, for example, a capacitive- or impedance-based sensor which mustdetect tissue before permitting activation of the power and controlsystem 400. These concepts are not mutually exclusive and one or morecombinations may be utilized within the breadth of the present inventionto prevent, for example, premature activation of the drug pump. In apreferred embodiment, the drug pump 10 utilizes one or more mechanicalon-body sensors. Additional integrated safety mechanisms are describedherein with reference to other components of the novel drug pumps.

Power and Control System:

The power and control system 400 includes a power source, which providesthe energy for various electrical components within the drug pump, oneor more feedback mechanisms, a microcontroller, a circuit board, one ormore conductive pads, and one or more interconnects. Other componentscommonly used in such electrical systems may also be included, as wouldbe appreciated by one having ordinary skill in the art. The one or morefeedback mechanisms may include, for example, audible alarms such aspiezo alarms and/or light indicators such as light emitting diodes(LEDs). The microcontroller may be, for example, a microprocessor. Thepower and control system 400 controls several device interactions withthe user and interfaces with the drive mechanism 100. In one embodiment,the power and control system 400 interfaces with the control arm 40 toidentify when the on-body sensor 24 and/or the activation mechanism 14have been activated. The power and control system 400 may also interfacewith the status indicator 16 of the pump housing 12, which may be atransmissive or translucent material which permits light transfer, toprovide visual feedback to the user. The power and control system 400interfaces with the drive mechanism 100 through one or moreinterconnects to relay status indication, such as activation, drugdelivery, and end-of-dose, to the user. Such status indication may bepresented to the user via auditory tones, such as through the audiblealarms, and/or via visual indicators, such as through the LEDs. In apreferred embodiment, the control interfaces between the power andcontrol system and the other components of the drug pump are not engagedor connected until activation by the user. This is a desirable safetyfeature that prevents accidental operation of the drug pump and mayadditionally maintain the energy contained in the power source duringstorage, transportation, and the like.

The power and control system 400 may be configured to provide a numberof different status indicators to the user. For example, the power andcontrol system 400 may be configured such that after the on-body sensorand/or trigger mechanism have been pressed, the power and control system400 provides a ready-to-start status signal via the status indicator 16if device start-up checks provide no errors. After providing theready-to-start status signal and, in an embodiment with the optionalon-body sensor, if the on-body sensor remains in contact with the bodyof the user, the power and control system 400 will power the drivemechanism 100 to begin delivery of the drug treatment through the fluidpathway connection 300 and sterile fluid conduit 30. In a preferredembodiment of the present invention, the insertion mechanism 200 and thefluid pathway connection 300 may be caused to activate directly by useroperation of the activation mechanism 14. During the drug deliveryprocess, the power and control system 400 is configured to provide adispensing status signal via the status indicator 16. After the drug hasbeen administered into the body of the user and after the end of anyadditional dwell time, to ensure that substantially the entire dose hasbeen delivered to the user, the power and control system 400 may providean okay-to-remove status signal via the status indicator 16. This may beindependently verified by the user by viewing the drive mechanism anddrug dose delivery through the window 18 of the pump housing 12.Additionally, the power and control system 400 may be configured toprovide one or more alert signals via the status indicator 16, such asfor example alerts indicative of fault or operation failure situations.

The power and control system 400 may additionally be configured toaccept various inputs from the user to dynamically control the drivemechanisms 100 to meet a desired drug delivery rate or profile. Forexample, the power and control system 400 may receive inputs, such asfrom partial or full activation, depression, and/or release of theactivation mechanism 14, to set, initiate, stop, or otherwise adjust thecontrol of the drive mechanism 100 via the power and control system 400to meet the desired drug delivery rate or profile. Similarly, the powerand control system 400 may be configured to receive such inputs toadjust the drug dose volume; to prime the drive mechanism, fluid pathwayconnection, and fluid conduit; and/or to start, stop, or pause operationof the drive mechanism 100. Such inputs may be received by the userdirectly acting on the drug pump 10, such as by use of the activationmechanism 14 or a different control interface, or the system 400 may beconfigured to receive such inputs from a remote control device.Additionally or alternatively, such inputs may be pre-programmed.

Other power and control system configurations may be utilized with thenovel drug pumps of the present invention. For example, certainactivation delays may be utilized during drug delivery. As mentionedabove, one such delay optionally included within the systemconfiguration is a dwell time which ensures that substantially theentire drug dose has been delivered before signaling completion to theuser. Similarly, activation of the device may require a delayeddepression (i.e., pushing) of the activation mechanism 14 of the drugpump 10 prior to drug pump activation. Additionally, the system mayinclude a feature which permits the user to respond to the end-of-dosesignals and to deactivate or power-down the drug pump. Such a featuremay similarly require a delayed depression of the activation mechanism,to prevent accidental deactivation of the device. Such features providedesirable safety integration and ease-of-use parameters to the drugpumps. An additional safety feature may be integrated into theactivation mechanism to prevent partial depression and, therefore,partial activation of the drug pumps. For example, the activationmechanism and/or power and control system may be configured such thatthe device is either completely off or completely on, to prevent partialactivation. Such features are described in further detail hereinafterwith regard to other aspects of the novel drug pumps.

Insertion Mechanism:

A number of insertion mechanisms may be utilized within the drug pumpsof the present invention. The pump-type delivery devices of the presentinvention may be connected in fluid flow communication to a patient oruser, for example, through any suitable hollow tubing. A solid boreneedle may be used to pierce the skin of the patient and place a hollowcannula at the appropriate delivery position, with the solid bore needlebeing removed or retracted prior to drug delivery to the patient. Asstated above, the fluid can be introduced into the body through anynumber of means, including but not limited to: an automatically insertedneedle, cannula, micro-needle array, or infusion set tubing. A number ofmechanisms may also be employed to activate the needle insertion intothe patient. For example, a biasing member such as a spring may beemployed to provide sufficient force to cause the needle and cannula topierce the skin of the patient. The same spring, an additional spring,or another similar mechanism may be utilized to retract the needle fromthe patient. In a preferred embodiment, the insertion mechanism maygenerally be as described in International Patent Application No.PCT/US2012/53174, which is included by reference herein in its entiretyfor all purposes. Such a configuration may be utilized for insertion ofthe drug delivery pathway into, or below, the skin (or muscle) of thepatient in a manner that minimizes pain to the patient. Other knownmethods for insertion of a fluid pathway may be utilized and arecontemplated within the bounds of the present invention.

In at least one embodiment, the insertion mechanism 200 includes aninsertion mechanism housing having one or more lockout windows, and abase for connection to the assembly platform and/or pump housing (asshown in FIG. 1B and FIG. 1C). The connection of the base to theassembly platform 20 may be, for example, such that the bottom of thebase is permitted to pass-through a hole in the assembly platform topermit direct contact of the base to the body of the user. In suchconfigurations, the bottom of the base may include a sealing membranethat is removable prior to use of the drug pump 10. The insertionmechanism may further include one or more insertion biasing members, aneedle, a retraction biasing member, a cannula, and a manifold. Themanifold may connect to sterile fluid conduit 30 to permit fluid flowthrough the manifold, cannula, and into the body of the user during drugdelivery.

As used herein, “needle” is intended to refer to a variety of needlesincluding but not limited to conventional hollow needles, such as arigid hollow steel needles, and solid core needles more commonlyreferred to as “trocars.” In a preferred embodiment, the needle is a 27gauge solid core trocar and in other embodiments, the needle may be anysize needle suitable to insert the cannula for the type of drug and drugadministration (e.g., subcutaneous, intramuscular, intradermal, etc.)intended. A sterile boot may be utilized within the needle insertionmechanism. The sterile boot is a collapsible sterile membrane that is infixed engagement at a proximal end with the manifold and at a distal endwith the base. In at least on embodiment, the sterile boot is maintainedin fixed engagement at a distal end between base and insertion mechanismhousing. Base includes a base opening through which the needle andcannula may pass-through during operation of the insertion mechanism, aswill be described further below. Sterility of the cannula and needle aremaintained by their initial positioning within the sterile portions ofthe insertion mechanism. Specifically, as described above, needle andcannula are maintained in the sterile environment of the manifold andsterile boot. The base opening of base may be closed from non-sterileenvironments as well, such as by for example a sealing membrane 254(shown in FIG. 1C).

According to at least one embodiment of the present invention, theinsertion mechanism is initially locked into a ready-to-use stage bylockout pin(s) which are initially positioned within lockout windows ofthe insertion mechanism housing. In this initial configuration,insertion biasing member and retraction biasing member are each retainedin their compressed, energized states. As shown in FIG. 1B, the lockoutpin(s) 208 may be directly displaced by user depression of theactivation mechanism 14. As the user disengages any safety mechanisms,such as an optional on-body sensor 24 (shown in FIG. 1C), the activationmechanism 14 may be depressed to initiate the drug pump. Depression ofthe activation mechanism 14 may directly cause translation ordisplacement of control arm 40 and directly or indirectly causedisplacement of lockout pin(s) 208 from their initial position withinlocking windows 202A of insertion mechanism housing 202. Displacement ofthe lockout pin(s) 208 permits insertion biasing member to decompressfrom its initial compressed, energized state. This decompression of theinsertion biasing member drives the needle and the cannula into the bodyof the user. At the end of the insertion stage, the retraction biasingmember is permitted to expand in the proximal direction from its initialenergized state. This axial expansion in the proximal direction of theretraction biasing member retracts the needle, while maintaining thecannula in fluid communication with the body of the user. Accordingly,the insertion mechanism may be used to insert a needle and cannula intothe user and, subsequently, retract the needle while retaining thecannula in position for drug delivery to the body of the user.

Drive Mechanism:

A number of drive mechanisms may be utilized to force fluid from a drugcontainer for delivery into the body of a user. In one such embodiment,the drive mechanism 100 may be substantially similar to that describedin International Patent Application No. PCT/US2012/053241, which isincluded by reference herein in its entirety for all purposes. As shownin FIG. 2A, a drug container may have a drug chamber 21 within thebarrel 58 between a sliding pierceable seal 56 and a plunger seal 60.The drug chamber 21 may contain a drug fluid for delivery throughintegrated sterile fluid pathway connection, the fluid restrictionmechanism, the insertion mechanism, and drug pump into the body of theuser. The seals described herein may be comprised of a number ofmaterials but are, in a preferred embodiment, comprised of one or moreelastomers or rubbers. The drive mechanism 100 may contain one or moredrive biasing members to drive the plunger seal 60. The components ofthe drive mechanism function to force a fluid from the drug chamber 21out through fluid pathway connection 300, through the fluid restrictionmechanism 500 where it may be controlled by restriction or by increasedfluid travel time through the fluid pathway, to the sterile fluidconduit 30, and insertion mechanism 200 into the body of the user. Forclarity, the fluid restriction mechanism 500 may be an aspect orcomponent of the sterile fluid pathway connection 300 or be a separatecomponent, as detailed further herein. The fluid restriction mechanism500 may be connected at the beginning of the fluid conduit 30, betweenthe sterile fluid pathway connection 300 and the fluid conduit 30, atthe end of the fluid conduit 30, between the fluid conduit 30 and theinsertion mechanism 200, or anywhere in between along the fluid conduit30.

In one particular embodiment, the drive mechanism 100 employs one ormore compression springs as the biasing member(s). Upon activation ofthe drug pump by the user, the power and control system 400 may beactuated to directly or indirectly release the compression spring(s)from an energized state. Upon release, the compression spring(s) maybear against and act upon the plunger seal 60 to force the fluid drugout of the drug chamber 21 of the drug container. Once the sterile fluidpathway connection 300 is connected or opened, drug fluid is permittedto flow from the drug container, through the sterile fluid pathwayconnection, fluid restriction mechanism, sterile fluid conduit, andinsertion mechanism, and into the body of the user for drug delivery.

Fluid Pathway Connection:

A number of fluid pathway connections may be utilized within theembodiments of the present invention. Generally, a suitable fluidpathway connection includes a sterile fluid conduit, a piercing member,and a sterile sleeve attached to a drug container or a slidingpierceable seal integrated within a drug container. The fluid pathwayconnection may further include one or more flow restrictors. Upon properactivation of the device 10, the fluid pathway connection 300 is enabledto connect the sterile fluid conduit 30 to the drug container of thedrive mechanism 100. Such connection may be facilitated by a piercingmember, such as a needle, penetrating a pierceable seal of the drugcontainer of the drive mechanism 100. The sterility of this connectionmay be maintained by performing the connection within a flexible sterilesleeve. Upon substantially simultaneous activation of the insertionmechanism, the fluid pathway between drug container and insertionmechanism is complete to permit drug delivery into the body of the user.

In at least one embodiment of the present invention, the piercing memberof the fluid pathway connection is caused to penetrate the pierceableseal of the drug container of the drive mechanism by direct action ofthe user, such as by depression of the activation mechanism by the user.For example, the activation mechanism itself may bear on the fluidpathway connection such that displacement of the activation mechanismfrom its original position also causes displacement of the fluid pathwayconnection. In one such embodiment, the fluid pathway connection may besubstantially similar to that described in International PatentApplication No. PCT/US2012/054861, which is included by reference hereinin its entirety for all purposes. According to such an embodiment, theconnection is enabled by the user depressing the activation mechanismand, thereby, driving the piercing member through the pierceable seal,because this prevents fluid flow from the drug container until desiredby the user. In such an embodiment, a compressible sterile sleeve may befixedly attached between the cap of the drug container and theconnection hub of the fluid pathway connection. The piercing member mayreside within the sterile sleeve until a connection between the fluidconnection pathway and the drug container is desired. The sterile sleevemay be sterilized to ensure the sterility of the piercing member and thefluid pathway prior to activation.

Alternatively, the fluid pathway connection may be integrated into adrug container as described in International Patent Application No.PCT/US2013/030478, for example, which is included by reference herein inits entirety for all purposes. According to such an embodiment, a drugcontainer may have a drug chamber within a barrel between a pierceableseal and a plunger seal. A drug fluid is contained in the drug chamber.Upon activation of the device by the user, a drive mechanism asserts aforce on a plunger seal contained in the drug container. As the plungerseal asserts a force on the drug fluid and any air/gas gap or bubble, acombination of pneumatic and hydraulic pressure builds by compression ofthe air/gas and drug fluid and the force is relayed to the slidingpierceable seal. The sliding pierceable seal is caused to slide towardsthe cap, causing it to be pierced by the piercing member retained withinthe integrated sterile fluid pathway connection. Accordingly, theintegrated sterile fluid pathway connection is connected (i.e., thefluid pathway is opened) by the combination pneumatic/hydraulic force ofthe air/gas and drug fluid within the drug chamber created by activationof a drive mechanism. Once the integrated sterile fluid pathwayconnection is connected or opened, drug fluid is permitted to flow fromthe drug container, through the integrated sterile fluid pathwayconnection, sterile fluid conduit, and insertion mechanism, and into thebody of the user for drug delivery. In at least one embodiment, thefluid flows through only a manifold and a cannula and/or needle of theinsertion mechanism, thereby maintaining the sterility of the fluidpathway before and during drug delivery.

Regardless of the fluid pathway connection utilized by the drug pump,the drug pump is capable of delivering a range of drugs with differentviscosities and volumes. The drug pump is capable of delivering a drugat a controlled flow rate (speed) and/or of a specified volume. In oneembodiment, the drug delivery process is controlled by one or more flowrestrictors within the fluid pathway connection and/or the sterile fluidconduit. In other embodiments, other flow rates may be provided byvarying the geometry of the fluid flow path or delivery conduit, varyingthe speed at which a component of the drive mechanism advances into thedrug container to dispense the drug therein, or combinations thereof.Still further details about the fluid pathway connection 300 and thesterile fluid conduit 30 are provided hereinafter in later sections inreference to other embodiments.

Fluid Restriction Mechanism:

The fluid restriction mechanisms of the present invention may take anumber of configurations while remaining within the scope of thepresently claimed embodiments. The fluid restriction mechanisms providea means for fluid delivery control, by restricting the flow of fluidtravel and/or by increasing the length of the fluid pathway that thefluid must travel through between the drug container and the insertionmechanism before delivery into the patient. The fluid restrictionmechanisms of the present invention are readily replaceable,configurable, and/or stackable to enable the drug delivery device tomeet the desired drug delivery profile (e.g., delivery duration). Thefluid restriction mechanism 500 may be connected to the sterile fluidconduit 30, preferably, between the fluid pathway connection 300 and theinsertion mechanism 200. For example, the fluid restriction mechanism500 may be connected at the beginning of the fluid conduit 30 (betweenthe sterile fluid pathway connection 300 and the fluid conduit 30), atthe end of the fluid conduit 30 (between the fluid conduit 30 and theinsertion mechanism 200), or anywhere in between along the fluid conduit30.

The fluid restriction mechanism 500 resides within the housing of thedrug pump, as shown in FIG. 1B. FIG. 2A shows an isometric view of afluid restriction mechanism, according to at least one embodiment of thepresent invention, attached to an integrated sterile fluid pathwayconnection and drug container. In such an embodiment, the fluidrestriction mechanism may be a component of the integrated sterile fluidpathway connection and drug container. As shown in FIG. 2B, the fluidrestriction mechanism may be attached to the sterile fluid pathwayconnection and drug container, such as by retention by cap 52 which maybe a cap that is crimped to the barrel 58. In this configuration, thefluid restriction mechanism may include a piercing member 510, such as aneedle, that is capable of piercing a seal 56 of the sterile fluidpathway connection 300 to permit fluid flow from the drug chamber 21 ofbarrel 58 of the drug container 50. In this configuration, the seal 56is caused to slide upon, and be pierced by the piercing member 510 uponhydraulic and/or pneumatic pressure of the fluid within the drug chamber21 that is caused by a drive mechanism 100 (shown in FIG. 1C) actingupon plunger seal 60. Once the sterile fluid pathway connection 300 isopened, drug fluid may travel through piercing member 510, through thefluid channel(s) of the fluid restriction mechanism 500, out throughport 512 through the fluid conduit 30 to the insertion mechanism 200 fordrug delivery to the patient. FIG. 2C shows a side view of the fluidrestriction mechanism shown in FIG. 2A. As will be detailed furtherherein, the fluid restriction mechanism 500 may also include a membrane309, such as a partially permeable membrane, that is capable of ventingair or other gas from the sterile cavity between the fluid restrictionmechanism 500 and the seal 56. In such a configuration, the fluidrestriction mechanism 500 does not need to move or translate onceassembled to barrel 58 of the drug container 50 as the sterile fluidpathway connection 300 occurs integrated within the drug container 50.This configuration of the fluid restriction mechanism may be preferredfor use with the integrated fluid pathway connection and drug containerdescribed in International Patent Application No. PCT/US2013/030478.

FIG. 3A shows an isometric view of a fluid restriction mechanism,according to another embodiment of the present invention. In thisconfiguration, the fluid restriction mechanism 1500 is attached to asterile fluid pathway connection which may or may not be integratedwithin the drug container. In this configuration, the seal 56 may beretained in position at the distal end of the barrel 58 by cap 52, andthe sterile fluid pathway connection 300 may be external (i.e., notintegrated) to the barrel 58 of the drug container 50. Thisconfiguration of the fluid restriction mechanism may be preferred foruse with the fluid pathway connection and drug container described inInternational Patent Application No. PCT/US2012/054861. The fluidrestriction mechanism 1500 of this embodiment may be attached to thedistal end of the sterile fluid pathway connection 300 which is capableof acting upon and piercing the seal 56 retained within barrel 58 of thedrug container 50. In that embodiment, the piercing member 1510 wouldinstead be a conduit or port connected to the distal surface of thefluid pathway connection. Alternatively, a piercing member 1510 may beutilized in this embodiment to function as part of the integrated fluidpathway connection and drug container, and to pierce the seal 56 topermit drug flow from the drug container 50. FIG. 3B shows an explodedisometric view of the fluid restriction mechanism, and sterile fluidpathway connection and drug container, shown in FIG. 3A. FIG. 3C shows aside view of the fluid restriction mechanism shown in FIG. 3A.

FIG. 4A shows an exploded isometric view of the fluid restrictionmechanism shown in FIGS. 2A-2C. Though the description below providesdetails with reference to the embodiments shown in FIGS. 2A-2C, thedescription with reference to the function of the fluid restrictionmechanism may also provide detail to the embodiments shown in FIGS.3A-3C. FIG. 4A shows the fluid restriction mechanism 500 as two separatecomponents. FIG. 4B shows another angle of the exploded isometric viewof the fluid restriction mechanism shown in FIG. 4A. As would beunderstood by one having ordinary skill in the relevant art, this isprimarily for ease of manufacture and the mechanism 500 may be a singleunified component if manufactured, for example, by injection molding orother suitable means. In this two-part assembly the fluid channel(s) maybe imparted, such as by carving or other suitable means of manufacture,onto a first component 500B of the fluid restriction mechanism and thenclosed by attachment of a second component 500A. The two components maybe affixed and held together by snap arms, adhesives, etc., or othermechanisms which are readily known in the industry to provide a tightseal to the fluid channel(s) of the fluid restriction mechanism. Thesecond component (e.g., cover plate) 500A may be fused, molded, orotherwise connected to the first component (e.g., restriction plate)500B. The fluid pathway of each of the fluid channels may be adjustedfor pathway thickness, length, curvature, and any number of tortuouspath parameters, for example, to produce a fluid restriction of anydesired range. The pathway that a drug fluid may travel through thefluid restriction mechanism 500 is shown with reference to FIG. 4C,which provides a cross-sectional view of the fluid restriction mechanismshown in FIGS. 4A-4B. Drug fluid may enter the fluid restrictionmechanism 500 through aperture 520A of a piercing member 510. The drugfluid then enters the fluid channel(s) at entry point 520B. The drugfluid is retained in the fluid channel(s) 520C because of the tight sealprovided by the mating of the second component 500A to the firstcomponent 500B.

In the embodiment shown, the fluid channel(s) are in a spiral shape toelongate the length of travel that the fluid must pass (i.e., extendingthe time or duration of drug delivery). The width of the channel(s) mayalso be modified and utilized to control the flow parameters through thefluid restriction mechanism. The drug fluid then travels through thefluid channel(s) 520C to exit point 520D, at which point the drug fluidis caused to travel through outlet aperture 514 of port 512 to the fluidconduit 30 (visible in FIGS. 2A-2C). The fluid channel(s) may beshortened or lengthened to provide the desired duration of fluiddelivery time (i.e., the drug fluid may be caused to travel a longerpath or a shorter path through the fluid restriction mechanism).Additionally or alternatively, the fluid channel(s) may restrict theflow of drug fluid by functioning as an orifice. As would be readilyunderstood by an ordinarily skilled artisan in the relevant arts, fluidflow in a pipe or conduit is always accompanied by friction of fluidparticles rubbing against one another, and consequently, by loss ofenergy available for work. In other words, there must be a pressure dropin the direction of flow. Accordingly, the fluid channel(s) of the fluidrestriction mechanism may function as an orifice to meter rate of flow,by restricting flow and/or to reduce pressure. For liquid flow, severalorifices are sometimes used to reduce pressure in steps so as to avoidcavitation. Concurrently, a vent aperture 530A, 530B may be utilized tovent the air or gas from the proximal side of the fluid restrictionmechanism 500 to the distal side of the fluid restriction mechanism 500.A membrane 309, such as a partially permeable membrane, may be utilizedfor example to facilitate the passage of gas (e.g., air) in onedirection while preventing fluid passage therethrough.

FIGS. 5A-5B show a configurable fluid restriction mechanism, accordingto another embodiment of the present invention, in the exploded andfront views respectively. In this embodiment, the fluid restrictionmechanism 500 contains more than one fluid channel 520C, 521C, 522C, and523C. Accordingly, the same fluid restriction mechanism 500 may beutilized in a number of configurations to provide the desired fluid flowparameters. If shorter drug delivery duration is desired, channel 522Cmay be selected and aligned with entry point 520B and exit point 520D.If more restrictive fluid flow is desired, channel 523C may be selectedand aligned with entry point 520B and exit point 520D. Alternatively,channels 521C or 520C may be selected and aligned with entry point 520Band exit point 520D to reach the desired drug delivery parameters. Thisis facilitated, for example during assembly of the device, byidentifying the desired drug delivery parameters and the appropriatefluid channel, and rotating and mounting the fluid chip 550A into thecorresponding recess 550B such that the selected fluid channel alignswith entry point 520B and exit point 520D. This is shown in FIG. 5B.

Any number of distinct channels may be provided and utilized in thisembodiment of a configurable fluid restriction mechanism. Additionally,the desired channels may be opened or closed by removing or adding,respectively, barriers between the channels. For example, if an evenlonger fluid channel is desired, the barriers between channels 521C and520C may be modified such that the fluid flows initially into channel520C through entry point 520B, then through channel 521C, then backthrough the remainder of channel 520C to exit point 520D. In a furtherembodiment, the fluid restriction plate may have a number of sequentialor parallel pathways which are configurable to deliver the desired fluidrestriction parameters. For example, the fluid restriction plate mayhave a number of different pathways of different lengths andconstraints, and the specifically desired fluid pathway may be selectedduring assembly to produce the desired fluid restriction for the drugpump system. One or more of these pathways may be “opened” or “closed”prior to assembly to enable a range of configurable fluid pathways.While plates are discussed and shown herein, the fluid restrictors maytake on a number of different shapes and configurations including, butnot limited to, spheres, discs, pucks, semicircles, rectangles, cubes,pyramids, and the like. This configurability provides even morevariation to the number of channels or fluid path configurations capableof being employed by the present invention. More complex shapes may beutilized which include different fluid pathway channels, and these areonly restricted by economically-feasible and known manufacturingmethods. For example, more complex shapes and fluid channelconfigurations may be possible via 3D-printing, or other complexmanufacturing methods. Concurrently, a vent aperture 530A, 530B may beutilized to vent the air or gas from the proximal side of the fluidrestriction mechanism 500 to the distal side of the fluid restrictionmechanism 500. A membrane 309, such as a partially permeable membrane,may be utilized for example to facilitate the passage of gas (e.g., air)in one direction while preventing fluid passage therethrough.

FIG. 6A shows an isometric view of a stackable fluid restrictionmechanism, according to another embodiment of the present invention.FIG. 6B shows an exploded isometric view of the stackable fluidrestriction mechanism. The stackable fluid restriction mechanism mayutilize any of the fluid restriction arrangement described above withreference to FIG. 4A and FIG. 5A, in the configurations shown in FIGS.2A-2C, FIGS. 3A-3C, or the other configurations described herein.Accordingly, one or more fluid restriction mechanisms may be utilized ina stacked configuration to provide an additional distance that the drugfluid must travel to prolong the duration of drug delivery. In such astacked configuration, a spacer plate 503B may be utilized between tworestriction plates 503A and 500B, in order to align the fluid entrypoints and exit points with the corresponding or abutting plates. Anynumber of these plates may be utilized to reach the desired drugdelivery parameters.

The fluid restriction mechanisms of the present invention are shownprimarily in a disc-shaped configuration, though the shape is not anecessary limitation on the present invention and any number of knownshapes may be utilized. For example, FIG. 7A shows an isometric view ofa rectangular fluid restriction mechanism, according to a furtherembodiment of the present invention. FIG. 7B shows the isometric view ofthe fluid restriction mechanism shown in FIG. 7A, with the top componentof the fluid restriction mechanism removed. As shown, the fluidrestriction mechanism may take any number of shapes or dimensions,provided that there is at least one fluid channel therein having atleast one entry point and at least one exit point through which the drugfluid may travel. Additionally, the fluid restriction mechanism 500 maybe connected to the sterile fluid conduit 30, preferably, between thefluid pathway connection 300 and the insertion mechanism 200. Forexample, the fluid restriction mechanism 500 may be connected at thebeginning of the fluid conduit 30 (between the sterile fluid pathwayconnection 300 and the fluid conduit 30), at the end of the fluidconduit 30 (between the fluid conduit 30 and the insertion mechanism200), or anywhere in between along the fluid conduit 30 (as shown inFIG. 7A-7B).

Assembly and/or manufacturing of fluid restriction mechanism 500, drugdelivery pump 10, or any of the individual components may utilize anumber of known materials and methodologies in the art. For example, anumber of known cleaning fluids such as isopropyl alcohol and hexane maybe used to clean the components and/or the devices. A number of knownadhesives or glues may similarly be employed in the manufacturingprocess. Additionally, known siliconization and/or lubrication fluidsand processes may be employed during the manufacture of the novelcomponents and devices. Furthermore, known sterilization processes maybe employed at one or more of the manufacturing or assembly stages toensure the sterility of the final product.

A fluid pathway connection, and specifically a sterile sleeve of thefluid pathway connection, may be connected to the cap and/or pierceableseal of the drug container. The fluid restriction mechanism may beconnected to the other end of the fluid pathway connection. A fluidconduit may be connected to the fluid restriction mechanism at one endand the insertion mechanism at the other end, such that the fluidpathway, when opened, connected, or otherwise enabled travels directlyfrom the drug container, fluid pathway connection, fluid restrictionmechanism, fluid conduit, insertion mechanism, and through the cannulafor drug delivery into the body of a user. As described above, the fluidrestriction mechanism may alternatively be located between the sterilepathway connection and the insertion mechanism such that a first fluidconduit is connected directly to the sterile pathway connection and tothe fluid restriction mechanism, and then a second fluid conduit isconnected to the fluid restriction mechanism and to the insertionmechanism. Regardless of the configuration, or order of components, thefluid pathway, when opened, connected, or otherwise enabled travelsdirectly from the drug container, fluid pathway connection, fluidrestriction mechanism, fluid conduit, insertion mechanism, and throughthe cannula for drug delivery into the body of a user. The componentswhich constitute the pathway for fluid flow are now assembled. Thesecomponents may be sterilized, by a number of known methods, and thenmounted either fixedly or removably to an assembly platform or housingof the drug pump, as shown in FIG. 1B.

Certain optional standard components or variations of fluid restrictionmechanism 500 or drug pump 10 are contemplated while remaining withinthe breadth and scope of the present invention. For example, the drugpump 10 may contain an adhesive patch 26 and a patch liner 28 on thebottom surface of the housing 12. The adhesive patch 26 may be utilizedto adhere the drug pump 10 to the body of the user for delivery of thedrug dose. As would be readily understood by one having ordinary skillin the art, the adhesive patch 26 may have an adhesive surface foradhesion of the drug pump to the body of the user. The adhesive surfaceof the adhesive patch 26 may initially be covered by a non-adhesivepatch liner 28, which is removed from the adhesive patch 26 prior toplacement of the drug pump 10 in contact with the body of the user.Removal of the patch liner 28 may further remove the sealing membrane254 of the insertion mechanism 200, opening the insertion mechanism tothe body of the user for drug delivery (as shown in FIG. 1C).

Similarly, one or more of the components of fluid restriction mechanism500 and drug pump 10 may be modified while remaining functionally withinthe breadth and scope of the present invention. For example, asdescribed above, while the housing of drug pump 10 is shown as twoseparate components upper housing 12A and lower housing 12B, thesecomponents may be a single unified component. As discussed above, aglue, adhesive, or other known materials or methods may be utilized toaffix one or more components of the fluid restriction mechanism and/ordrug pump to each other. Alternatively, one or more components of thefluid restriction mechanism and/or drug pump may be a unified component.For example, the upper housing and lower housing may be separatecomponents affixed together by a glue or adhesive, a screw fitconnection, an interference fit, fusion joining, welding, ultrasonicwelding, and the like; or the upper housing and lower housing may be asingle unified component. Such standard components and functionalvariations would be appreciated by one having ordinary skill in the artand are, accordingly, within the breadth and scope of the presentinvention.

Throughout the specification, the aim has been to describe the preferredembodiments of the invention without limiting the invention to any oneembodiment or specific collection of features. Various changes andmodifications may be made to the embodiments described and illustratedwithout departing from the present invention. The disclosure of eachpatent and scientific document, computer program and algorithm referredto in this specification is incorporated by reference in its entirety.

1.-20. (canceled)
 21. A fluid restriction mechanism for a drug deliverypump, comprising: a first component including a piercing member; and asecond component connected to the first component, the second componentincluding an outlet port configured to mate with a fluid conduit, atleast one of the first and second components including a fluid channel,the fluid channel including an entry point in fluid communication withthe piercing member and an exit point in fluid communication with theoutlet port.
 22. The fluid restriction mechanism of claim 21, furthercomprising a fluid chip that includes at least a portion of the fluidchannel, at least one of the first and second components including arecess configured to receive the fluid chip.
 23. The fluid restrictionmechanism of claim 22, wherein the fluid chip comprises a plurality offluid channels.
 24. The fluid restriction mechanism of claim 23, whereinthe fluid chip is configured to selectably align at least one of theplurality of fluid channels with the entry point and the exit point. 25.The fluid restriction mechanism of claim 23 wherein the plurality offluid channels vary in length.
 26. The fluid restriction mechanism ofclaim 23, wherein the plurality of fluid channels vary in diameter. 27.The fluid restriction mechanism of claim 23, wherein the plurality offluid channels vary in shape.
 28. The fluid restriction mechanism ofclaim 27 wherein one or more of the plurality of fluid channels areconfigured to connect.
 29. The fluid restriction mechanism of claim 21,wherein the first and second components are configured to provide afluid-tight seal of the fluid channel.
 30. The fluid restrictionmechanism of claim 21, wherein the first and second components areunitary.
 31. The fluid restriction mechanism of claim 21, furthercomprising a spacer plate and a restriction plate located between thefirst component and the second component, the spacer plate configured toalign the entry point or the exit point of the fluid channel with asecond fluid channel located in the restriction plate.
 32. The fluidrestriction of mechanism of claim 21, wherein the first componentincludes a first vent aperture and the second component includes asecond vent aperture, the first and second vent apertures configured tovent air or gas from a proximal side of the fluid restriction mechanismto a distal side of the fluid restriction mechanism.
 33. The fluidrestriction mechanism of claim 32, further comprising a membraneconfigured to facilitate passage of gas while preventing passage offluid through at least one of the first and second vent apertures. 34.An integrated fluid restriction mechanism and drug container,comprising: the fluid restriction mechanism of claim 21; and a drugcontainer including: a cap, a barrel, and a plunger seal, at least aportion of the fluid restriction mechanism located between the cap and adistal end of the barrel.
 35. A drug delivery pump, comprising: housing;an activation mechanism; a drive mechanism; an insertion mechanism; afluid pathway connection including a fluid conduit and the fluidrestriction mechanism of claim 21; and a drug container connected at oneend to the drive mechanism and at another end to the fluid pathwayconnection, the outlet port of the fluid restriction mechanism connectedto one end of the fluid conduit, another end of the fluid conduitconnected to the insertion mechanism.
 36. The drug delivery pump ofclaim 35, wherein the fluid restriction mechanism is mounted to the drugcontainer.
 37. The drug delivery pump of claim 35, wherein the fluidrestriction mechanism is integrated within the drug container.
 38. Afluid restriction mechanism for a drug delivery pump, comprising: afirst component including a piercing member and an outlet portconfigured to mate with a fluid conduit; and a second component insealing engagement with the first component, at least one of the firstand second components including a fluid channel, the fluid channelincluding an entry point in fluid communication with the piercing memberand an exit point in fluid communication with the outlet port.